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By Kelly M. Pyrek

Editor's Note: ICT first reported on efforts by the Food and Drug Administration (FDA) and the Association for the Advancement of Medical Instrumentation (AAMI) to examine the state of medical device reprocessing in our 2012 Regulatory Update in January. This is an update on the issues.

Following a two-day summit convened by the FDA and AAMI in October 2011, AAMI released a post-event publication in December 2011 that captured the essence of the summit, outlined the priorities, and established a path forward.

In a prologue in the publication, "A Clean Start: Priority Issues from the AAMI/FDA Medical Device Reprocessing Summit," AAMI president Mary Logan and Pamela Scott, senior science advisor for reprocessing of reusable medical devices for the FDA, note, "Several attendees mentioned that the healthcare community has been talking about reprocessing issues and the challenge of following complex reprocessing instructions for almost 40 years. While we have made significant progress along the way, some of the frustrations and issues raised at the summit were obviously longstanding. We commend the willingness of healthcare and industry professionals to come together to address these important issues."

It is a formidable task, and one that will require immense collaboration, communication and perseverance if the end goal is to be achieved -- better reprocessing of reusable medical devices and improved patient outcomes. As Logan and Scott add, "Healthcare organizations which have experienced challenges associated with reusable medical devices, including the Veterans Administration, Tulane Medical Center, and Victoria General Hospital, join countless other hospitals and surgical centers in our recommitment to solving these old frustrations and issues because of their desire to prevent future patient events. On a more personal level, the countless patients who have been potentially or actually exposed to contaminated instruments resulting from inadequate reprocessing would fervently urge us to do something now. To do something now is exactly why we co-convened this important event. AAMI standards committees already are making plans and setting priorities on what can be addressed now and by whom. The FDA continues to seek out and capitalize on opportunities to improve the reprocessing of reusable medical devices through regulatory science. Working together, AAMI and the FDA will facilitate collaboration with other organizations, companies, and individuals to take the lead on different areas of the reprocessing challenge. No one group can do this alone, and the answer is not as simple as 'more standards' or 'more regulations.'”

The AAMI publication (2011) explains that the summit "crystallized a compendium of challenges and priority actions for delivering on patients’ basic expectation of cleanliness for reusable medical devices. Indeed, this 'patient safety first' focus — with the ideal of ensuring that reprocessing is done correctly every time — was a recurring message from summit participants. So, too, was the overarching challenge for all stakeholders to deepen knowledge and eliminate confusion about reprocessing requirements and to pay closer attention to human and environmental challenges."

AAMI's Seven Clarion Themes1. Gain consensus on “how clean is clean” and on adequate cleaning validation protocols for reprocessing reusable medical devices.2. Create standardized, clear instructions and repeatable steps for reprocessing whenever possible.3. Pay early, iterative, and comprehensive attention to reprocessing requirements throughout the device design process.4. Make human factors and work environment factors priorities when developing reprocessing requirements.5. Improve information collection and sharing to broaden the use of best practices in reprocessing.6. Improve reprocessing competencies by strengthening training, education and certification.7. Create a greater sense of urgency and understanding throughout the healthcare community about the consequences of inadequate reprocessing.]

Let's review the seven clarion themes in more detail.

1. Gain consensus on “how clean is clean” and on adequate cleaning validation protocols for reprocessing reusable medical devices.Summit attendees pointed to an overall lack of understanding and lack of a consistent definition for the meaning of “clean” for reprocessed medical devices, so there must be more research on the essential factors to be considered when defining “clean” for handling and reprocessing medical devices. Also needed is a common definition or explanation of “clean” for reprocessed medical devices. Summit attendees noted a lack of specific criteria and endpoints for measuring whether a device is clean, so the goal is to define acceptance criteria and analytical endpoints for determining “how clean is clean enough” for specific clinical uses of medical devices. Summit attendees emphasized a lack of standardization of clinically relevant test soils for validating the effectiveness of reprocessing methods, therefore there must be standardized test soils for validating the reprocessing of specific types of medical devices.

The variability in how "clean" is defined across standards and recommended practices further complicates matters. A dictionary such as Merriam-Webster defines “clean” as being “free from contamination or disease,” a definition that makes sense in the healthcare community, but this can be much too vague when validation of cleaning and decontamination processes are considered. For example, here's a look at various definitions from industry standards:- AAMI TIR 30 (a compendium of processes, materials, test methods and acceptance criteria for cleaning reusable medical devices and intended for manufacturers) defines clean as "Removal of contamination from an item to the extent necessary for further processing or for the intended use.”- ANSI/AAMI ST79 (a comprehensive guide to steam sterilization and sterility assurance in healthcare facilities intended for reprocessing personnel) defines it as: “Removal of contamination from an item to the extent necessary for further processing or for the intended use. … In healthcare facilities, cleaning consists of removal, usually with detergent and water, of adherent organic and inorganic soil (e.g., blood, protein substances, and other debris) from the surfaces, crevices, serrations, joints, and lumens of instruments, devices, and equipment by a manual or mechanical process that prepares items for safe handling and/or further decontamination.”- AS/NZS 4187 (cleaning, disinfecting, and sterilizing reusable medical and surgical instruments and equipment, and maintenance of associated environments in healthcare facilities) defines it as “Removal of soil and a reduction in the number of microorganisms from a surface, by a process such as washing with detergent solution without prior reprocessing.”- ASTM E2314 (standard test method for determination of effectiveness of cleaning processes for reusable medical instruments using a microbiologic method defines it as “Removal of foreign materials, including organic soil (for example, protein) and microorganisms from medical instruments.”

Defining clean is essential because the device manufacturer must provide validation of the reprocessing method, and the end user must provide verification to measure the effectiveness of reprocessing methods. Summit presenter Trabue Bryans, vice president and general manager at WuXi AppTec, a contract research firm, explains the distinction between the two processes:• Validation of the efficacy of reprocessing: “If I clean the device this way, will it be acceptable for use?”• End-user verification: “Did I clean the device to the acceptable level?”“What the testing lab does is different than what end users do,” Bryans says in the AAMI publication (2011). “Validation of efficacy does not have to be user-friendly, quick, or easy.” Validation does have to be sensitive (able to be measured to a specific level) and thorough (able to be correlated to complete recovery of soil).

The general procedure for validation (measuring cleaning efficacy) can be described as including the following steps:- Soil the device- Allow soil to simulate worst-case conditions (e.g., allow soil to penetrate lumens, allow soil to dry)- Clean the device according to the manufacturer’s instructions for use (IFU)- Extract the cleaned device with elution fluid or other solvents, or measure soil directly on the device (i.e., the radionuclide method for cleaning validation)- Test the extracted fluid for residual soil

Compounding this validation-studies issue is the challenge of determining the appropriate test soils that represent the soils from actual use for appropriate verification assays by end users. As the AAMI publication (2011) notes, "According to the Draft Guidance for Industry and FDA Staff: Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, which is not for implementation, the FDA recommends the use of a quantitative test method capable of measuring meaningful levels of clinically relevant soil to meet a related, predetermined cleaning endpoint. When choosing a test method, consideration should be given to the chemical constituents that the device is expected to come in contact with during actual clinical use, which should be adequately represented in the artificial soil. The FDA generally requests that at least two quantitatively measured components of soil be assayed as part of cleaning validation protocols."

Bryans adds that definitive biomarker guidance is needed to establish which markers are actually appropriate; ensure that the markers selected are measurable to appropriate levels; ensure test results are reliable and reproducible; standardize testing (e.g., soil) for categories of devices; and standardize test criteria across laboratories. Not only does Bryans question whether microbial markers should be eliminated completely or used in conjunction with other markers to allow for correlation of results, he also says that "Scientific data is needed to determine the levels of a marker that are considered clean, the lower limits of detection and variability of markers, and the cost of marker assays versus the value of the data." (AAMI, 2011) The FDA is aware of these challenges, says Steven Turtil, a biologist in the agency's Division of Surgical, Orthopedic, and Restorative Devices. “We’ve tried to identify, for ourselves, what is clean,” Turtil says. “The core issue is direct measurement of clinically relevant soil.” Turtil says the FDA is interested in exploring more standardized methods for validation of cleaning instructions. (AAMI, 2011)

2. Create standardized, clear instructions and repeatable steps for reprocessing whenever possible.Summit attendees said that complicated reprocessing instructions -- and many different sets of instructions for many medical devices -- for clinical and reprocessing staff with a wide variety of skills were a challenge. For the future, steps for improvement include taking clinical and reprocessing staff into account when developing reprocessing instructions and obtain their input; conducting usability testing; making instructions clear; writing reprocessing instructions for clinical and reprocessing staff instead of for engineers or regulators; making instructions available electronically for reprocessing sites with access to computer technology; and taking a few of the most commonly used and current reprocessing practices and validating to all of these practices so that reprocessing steps are repeatable in the real world.

According to the AAMI publication (2011), "The single purpose of reprocessing—rendering reusable medical devices safe for the next patient—is often obfuscated by manufacturers’ IFU. The IFU at times add confusion and conflict with standard processing methods, summit participants said. Inadequately reprocessed reusable medical devices are the unintended consequence of the demand to reprocess thousands of medical devices, with many distinct and complicated requirements set forth in lengthy IFU that may be inaccessible. Some IFU recommend specific cleaning, disinfection, or sterilization parameters that cannot be followed, are not consistent with AAMI standards, or are unintelligible to reprocessing staff.

Problematic IFUs are a concern to numerous sterile processing departments across the country, but in particular at large institutions that turn over an enormous number of instruments daily. For example, Johns Hopkins Hospital reprocesses approximately 37,000 instruments every day, including 500 instrument sets (with about 75 instruments per set), and 200 individual instruments. Linda Condon, an educator in the Central Sterile Processing Department there, says the total hospital inventory of different instruments requiring reprocessing tallies as high as 14,000. “Right now, it is impossible to follow manufacturers’ instructions for use,” Condon says, as reported in the AAMI publication (2011). She cites a lack of standardized cleaning processes as the major culprit and adds, “There are like instruments with different instructions, processes, and tools. There are complicated instructions with too many steps that are unreasonable, with too many variables. There is minimal repetition of tasks. Device IFU do not specify the brush size needed to clean specific devices. Staff have to work from memory or ‘hearsay.’ IFU expect people to read an awful lot, in an environment that is not conducive to do such. Nobody reads. It is easier to ask a neighbor or see what someone else is using.”

Condon says that standardization is needed for soaking time, brushing, rinsing and ultrasonic cleaning, and adds further, "Cleaning instructions should be simple, concise, and repeatable. Mechanical cleaning instructions should be specific, but broad enough to be used with any FDA-cleared washer.” Echoing Condon's sentiments is Sue Klacik, central sterile supply manager at Humility of Mary Health Partners and the AAMI representative for the International Association of Healthcare Central Service Materiel Management (IAHCSMM). "There are multiple IFU for all products, [including instructions] for inspecting, cleaning, function testing, and protective packaging,” Klacik says, as reported in the AAMI publication (2011). "For every instrument, you have to consult a different IFU. “Reprocessing of nine devices would take about an eight-hour day, but there is absolutely no consistency in the IFU.” Klacik points out inconsistencies between IFU and AAMI standards, including ANSI/AAMI ST 79:2010 and A1: 2010, Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities and AAMI TIR12:2010, Designing, testing, and labeling reusable medical devices for reprocessing in healthcare facilities: A guide for medical device manufacturers. Of 22 different manufacturers’ IFU for stainless steel, non-lumened, hand-held devices that she reviewed, 41 percent omitted the use of a washer-disinfector, 50 percent omitted the process of using a sonic cleaning method, and 86 percent omitted the use of a lubricant. “These are standardized processes, discussed in AAMI documents, but omitted in IFU,” Klacik says. “IFU don’t meet standards.” (AAMI, 2011)

Sometimes IFU are difficult to access, let alone understand. Rose Seavey, president of Seavey Healthcare Consulting, LLC, has experienced first-hand the difficulties associated with procuring specific IFUs from medical device manufacturers who believe that the onus is on the end user. Seavey says that it is important for the Joint Commission, the Centers for Disease Control and Prevention (CDC) and the Centers for Medicare and Medicaid Services (CMS) to reference AAMI and Association of periOperative Nurses (AORN) standards for reprocessing in their guidance documents because these are the documents that clinical and reprocessing personnel follow, and because they are specific, comprehensive, and evidence-based. Seavey makes these recommendations for IFU:

- IFU must be readily available, clear and specific to the device (especially for complicated devices), and cover categories of instruments- Design considerations, FDA labeling, and “like categories” should be standardized- Healthcare professionals and reprocessing personnel should be notified of updates or modifications to IFU in a consistent and timely manner- Vendor representatives should be knowledgeable about current, published standards and provide accurate information; they should also provide specific IFU in writing- Healthcare professionals should make an effort to obtain the specific IFU that they need, and use MedWatch to report any obstacles

3. Pay early, iterative and comprehensive attention to reprocessing requirements throughout the device design process.Summit attendees pointed out that reprocessing is often an afterthought in device design and that there is a lack of guidance for medical devices that must be disassembled and reassembled for reprocessing. The solution may lie in manufacturers making effective reprocessing a priority from the very beginning of device design development, and whenever possible, minimizing features such as lumens, channels, articulated surfaces, and/or finishes and materials that are difficult to clean. Manufacturers are being asked to take into account the reprocessing capacity of healthcare facilities and the reprocessing staff who will conduct reprocessing. In addition, they are asked to consider all potential soil types, locations and surfaces on devices when validating cleaning methods for the most difficult to clean areas. Ultimately, if a device cannot be cleaned effectively, manufacturers could be asked to redesign it. Devices should be designed to minimize the need to disassemble and reassemble them for reprocessing; however, if disassembly and reassembly are needed for reprocessing, manufacturers should provide clear instructions, with guidance on when in the process the device should be disassembled and reassembled (i.e., before or after cleaning and disinfection/sterilization).

Thomas Gilmore, senior manager of product development for cleaning, disinfection, and sterilization, Olympus America, Inc. says that device designers have made improvements to devices that make them easier to clean, and more changes are planned for the future. For example, a single-channel flexible bronchoscope that is resistant to heat and pressure and can withstand steam sterilization was introduced in 2006. Changes in device materials can also improve durability against oxidizing agents. Improved design geometry can eliminate stepped surfaces, sharp corners, and abrupt surface changes, which are particularly problematic in internal spaces. Devices should also be designed to avoid dead-end cavities that are hard to clean. Improvements to automated reprocessing equipment, and recent and significant advances in chemistry, are reducing reprocessing time and the need for contact with chemicals, increasing efficacy, and providing more environmentally friendly cleaning products. “Chemistry plays a fundamental role in the cleaning and reprocessing of reusable medical devices,” Gilmore says. “The two fundamental design criteria for chemistry are efficacy and material compatibility.” (AAMI, 2011)

4. Make human factors and work environment factors priorities when developing reprocessing requirements.Summit attendees were concerned about the lack of understanding about the human factors and the environmental work factors that affect reusable medical device reprocessing. What could alleviate these issues is validating that personnel can reprocess medical devices effectively, taking into consideration personal characteristics and professional conditions, such as demanding workloads, as well as validate that medical devices can be reprocessed effectively in the real-life conditions of reprocessing departments. An additional consideration is the clinical demands for reusable medical devices in reprocessing instructions. Too often, the time to complete the reprocessing steps according to the instructions exceeds the time constraints of clinical need for reprocessed reusable devices.

In order to better understand performance in the sterile processing department, it is essential to consider that many SPDs have limited resources and/or staff, and the reprocessing environment can be isolated, noisy, humid and poorly lit -- all factors that can hinder job function. In addition, the workflow can be complex, with high volumes, peak periods, rush jobs, and constant interruptions, and time for adequate reprocessing can be limited by clinical demands, workforce availability or equipment cycles. On top of all of this, sterile processing personnel have different cognitive and physical capabilities and limitations, knowledge and skills, and preferences that can impede job performance.